SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.

FDA DeterminedCause 2

PRODUCTION CONTROLS: Process Control

Action

Mindray DS USA, Inc. issued an "Urgent Product Recall" notification dated December 31, 2009 by certified mail. Consignees were informed of the affected product and requested to discard all remaining stock. Replacement product will be provided by the firm at no cost.
For further information, contact Mindray DS USA, Inc. at 1-201-995-8000.